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The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Endovascular Treatment arm to be implanted with Relay device |
|
| 2 | Active Comparator | Surgical Control, underwent open repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relay Thoracic Stent-Graft | Device | implant |
| |
| Open Repair |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects | The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met. | 1 year |
| Primary Safety Endpoint: Distribution of Major Adverse Events | The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Farber, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Hospital | Phoenix | Arizona | 85006 | United States | ||
| University of Arizona |
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Subjects screened and enrolled at 29 sites in the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | Relay Device Group | Endovascular Treatment arm |
| FG001 | Surgical Control Group | Open Surgical Repair arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Procedure |
Open surgery |
|
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of California-San Francisco | San Francisco | California | 94143 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010-2975 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rockford Memorial Hospital | Rockford | Illinois | 61103 | United States |
| Clarian Cardiovascular | Indianapolis | Indiana | 46202 | United States |
| Indiana Heart Hospial | Indianapolis | Indiana | 46250 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| The Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| New York Presbyterian Hospital --Columbia/Cornell University | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania/Penn Presbyterian | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| INOVA Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Sentara Heart Hospital | Norfolk | Virginia | 23510 | United States |
| University of Washington | Seattle | Washington | 98105 | United States |
| Aurora St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED | 97 patients |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Relay Device Group | Endovascular Treatment arm |
| BG001 | Surgical Control Group | Open Surgical Repair arm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects | The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met. | All subjects who underwent the Relay implant procedure (Intention to Treat) | Posted | Number | participants | 1 year |
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| Primary | Primary Safety Endpoint: Distribution of Major Adverse Events | The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure | The number of subjects who underwent the endovascular procedure or open surgical repair | Posted | Number | participants | 1 year |
|
|
Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relay Device Group | Endovascular Treatment arm | 68 | 120 | 97 | 120 | ||
| EG001 | Surgical Control Group | Open Surgical Repair arm | 45 | 60 | 58 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding events | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment |
| |
| Cardiac complications | Cardiac disorders | No source vocabulary | Systematic Assessment |
| |
| Endoleak | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment |
| |
| Hematology complications | Blood and lymphatic system disorders | No source vocabulary | Systematic Assessment | Includes anemia, coagulopathy, increased platelets |
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| Neurological complications | Nervous system disorders | No source vocabulary | Systematic Assessment | Includes stroke, paraplegia, paraparesis |
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| Pulmonary Complications | Respiratory, thoracic and mediastinal disorders | No source vocabulary | Systematic Assessment |
| |
| Renal/genitourinary complications | Renal and urinary disorders | No source vocabulary | Systematic Assessment |
| |
| Vascular complications | Vascular disorders | No source vocabulary | Systematic Assessment | Includes ruptures of untreated aneurysms, aortic dissecton |
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| Vascular access complications | Vascular disorders | No source vocabulary | Systematic Assessment | includes access difficulty, iliac artery injury |
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| General | General disorders | No source vocabulary | Systematic Assessment | includes a variety of event types (e.g., decreased nutritional intake, volume overload, etc.) |
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| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | No source vocabulary | Systematic Assessment |
| |
| Digestive/gastrointestinal complications | Gastrointestinal disorders | No source vocabulary | Systematic Assessment |
| |
| Dermatological complications | Skin and subcutaneous tissue disorders | No source vocabulary | Systematic Assessment |
| |
| Device malfunctions | Injury, poisoning and procedural complications | No source vocabulary | Non-systematic Assessment |
| |
| Trauma | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Events | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment | Includes procedural bleeding and post-procedural bleeding |
|
| Cardiac complications | Cardiac disorders | No source vocabulary | Systematic Assessment |
| |
| Endoleak | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment |
| |
| Hematology complications | Blood and lymphatic system disorders | No source vocabulary | Systematic Assessment | Includes anemia, coagulopathy, thrombocytopenia |
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| Neurological complications | Nervous system disorders | No source vocabulary | Systematic Assessment |
| |
| Pulmonary complications | Respiratory, thoracic and mediastinal disorders | No source vocabulary | Systematic Assessment |
| |
| Renal/genitourinary complications | Renal and urinary disorders | No source vocabulary | Systematic Assessment |
| |
| Vascular complications | Vascular disorders | No source vocabulary | Systematic Assessment |
| |
| Vascular Access Complications | Vascular disorders | No source vocabulary | Systematic Assessment |
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| General | General disorders | No source vocabulary | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | No source vocabulary | Systematic Assessment |
| |
| Digestive/gastrointestinal complications | Gastrointestinal disorders | No source vocabulary | Systematic Assessment |
| |
| Dermatological Complications | Skin and subcutaneous tissue disorders | No source vocabulary | Systematic Assessment |
| |
| Device Malfunctions | Injury, poisoning and procedural complications | No source vocabulary | Non-systematic Assessment |
| |
| Trauma | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment |
| |
| Localized pain | Injury, poisoning and procedural complications | No source vocabulary | Systematic Assessment |
| |
| Hepatic complications | Hepatobiliary disorders | No source vocabulary | Systematic Assessment |
|
Many subjects experienced more than one type of event.
Investigator must provide Bolton Medical with the proposed publication for review. Bolton Medical had 30 days to review and had discretion to make changes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Weiller | Bolton Medical, Inc. | 954-838-9699 | AWeiller@boltonmedical.com |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| >=65 years |
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| Male |
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